The present invention relates generally to an apparatus and method suitable for maintaining extracorporeal pneumoperitoneum at an abdominal fenestration during surgery, and more particularly to a quick connect and disconnect enclosure and method for insertion of instruments or a surgeon""s hand into the body cavity through a fenestration for access to organs and instruments within the cavity without loss of insufflation pressure.
Laparoscopy and endoscopy have become a preferred surgical procedure because it is minimally invasive of the patient""s body and, in many instances, can be performed in short-procedure facilities with minimal trauma and significantly reduced recuperation time. In some cases, a new procedure referred to as hand-assisted laparoscopy, or endoscopy, has been employed in which a small muscle splitting incision is made just large enough for admitting the surgeon""s hand into the abdominal cavity to enable palpation of organs and manipulation of surgical instruments, and to provide bio-physical feedback. Visual feedback is usually provided as well through an endoscope and TV monitor.
Several medical devices have been developed which make it possible for hand-assisted laparoscopy to be carried out in the abdominal cavity while under conditions of pneumoperitoneum. One device, for instance, by Patrick F. Leahy et al. disclosed in U.S. patent application Ser. No. 08/300,346 filed Mar. 29, 1995 (International Application PCT/US95/04202 published Oct. 29, 1995) provides a gas-tight sleeve which communicates with the abdominal cavity through an incision allowing the surgeon""s hand access through entry and exit openings at opposite ends of the sleeve. The exit opening is sealed around the incision by a flange adhesively attached to the external surface of the abdomen. After the hand is passed through the entry opening, the sleeve is sealed around the surgeon""s forearm by an adjustable cuff. A duckbill check valve disposed between the entry and exit openings forms with the exit opening a substantially gas-tight chamber which allows the surgeon to withdraw his hand from the insufflated cavity with only a slight drop in gas pressure which can be quickly restored.
Another device disclosed in U.S. Pat. No. 5,480,410 to Cuschieri et al. provides a gas-tight enclosure in which a resilient ring at an exit opening is squeezed by hand into an oblong shape for insertion through the abdominal incision, then allowed to expand to its original shape under the edge of the incision to seal the peritoneum and enclosure for sufflation. At least one entry opening is provided for passing an instrument or a surgeon""s hand into the enclosure. The enclosure may also include a surgical glove integrally sealed to the entry opening in a glove-box manner for allowing the surgeon""s hand sterile access through the exit opening to organs and instruments within the abdominal cavity.
None of these devices, however, satisfies the need for such a gas-tight enclosure which can be quickly disconnected and reconnected as often as necessary during hand-assisted laparoscopic or endoscopic surgery while the enclosure remains sealed in place around the surgeon""s hand, and which can maintain abdominal pneumoperitoneum during extended interruptions in an operation for other medical procedures.
Accordingly, it is an object of the present invention to provide a gas-tight extracorporeal pneumoperitoneum enclosure which is worn by the surgeon during hand-assisted laparoscopic or endoscopic surgery, which can be quickly disconnected from a patient as often as necessary in the course of an operation and reconnected while still sealed around the surgeon""s hand, which allows the surgeon to manipulate or palpate organs and instruments from within the abdominal cavity, and which provides bio-physical feedback from the surgeon""s hand under conditions of pneumoperitoneum.
Another object of the invention is to provide a surgical apparatus which can be continuously sealed around the surgeon""s hand and forearm and selectively connected around an open wound while maintaining pneumoperitoneum in the course of a hand-assisted laparoscopic or endoscopic operation, and which will maintain pneumoperitoneum within the body cavity during any interruptions for any other medical procedure in the course of an operation.
A still further object of the invention is to enable minimally invasive surgery with minimal risk of damage to the immune system, and with shorter healing time and less time needed for recuperation in a hospital.
A further object is to provide a disposable surgical device which is relatively simple in design and easy to use.
More specifically, in one embodiment, the extracorporeal pneumoperitoneum enclosure is a fluid and gas impermeable elongate fingerless sleeve having an open proximal end and a distal end with holes arranged to seal gas-tightly around the base of the surgeon""s thumb and each of the fingers. The sleeve section intermediate its ends is reversely-turned on itself before its proximal end is fastened either directly, or indirectly, onto a patient""s skin around an incision. Preferably, a quick connect and disconnect assembly at the proximal end of the sleeve gas-tightly seals to the skin around an incision allowing the surgeon to interrupt and resume a hand-assisted laparoscopic surgical procedure under conditions of pneumoperitoneum as often as needed without removing the sleeve from his/her hand. Integral with the quick connect and disconnect assembly is a pressure relief valve for preventing over-sufflation. At least one instrument port is provided in the cuff for admitting, without loss of gas pressure, surgical instruments.
In another embodiment of the extracorporeal pneumoperitoneum enclosure, a fluid and gas impermeable hemispheric envelope is sealed gas-tightly around the incision. A quick connect and disconnect assembly with integral pressure relief valve is secured around an open base for maintaining the abdominal cavity sufflated during interruptions in an operation. This embodiment also includes a sealable instrument port.
Upper and lower seal rings in both embodiments of the quick connect and disconnect assembly have respectively mating interfaces enabling the sleeve and envelope to be interchangeable without removing the lower seal ring previously attached to a patient.
The method for using the apparatus in a hand-assisted laparoscopic operation is as follows. A lower seal ring of the quick connect and disconnect assembly is adhesively sealed to the skin of the patient around the site where a small muscle-splitting incision is made through the abdomen wall and peritoneum. A wound liner and retractor may be inserted into the incision to protect the wound from contamination and to spread it apart for easier access. Wearing an inner surgical glove, the surgeon inserts his/her hand into the fingerless sleeve until the fingers extend completely through the holes and become tightly sealed around their bases. For extra precaution against leakage, an outer surgical glove is then placed over both the inner glove and the fingerless sleeve. The sleeve is then reversely turned on itself. An upper seal ring of the quick connect and disconnect assembly around the cuff of the glove is then sealingly interconnected with the lower seal ring and the abdomen and glove insufflated to the desired pressure either through a separate cannula or a port in the glove. The surgeon""s hand may then be inserted into the abdominal cavity and removed as often as necessary during a laparoscopic procedure. The port in the sleeve permits instruments to be inserted as often as needed. Any increase in sufflating gas pressure, caused by a sudden reduction in volume when inserting the hand, is prevented by the pressure relief valve in the quick connect and disconnect assembly.
Whenever the surgeon wishes to interrupt a surgical procedure while still maintaining pneumoperitoneum, the sleeve is disconnected from the lower seal ring, and in its place the dome-like envelope with upper seal ring are connected to the lower seal ring left on the abdomen and sufflation restored.
Other objects, advantages and novel features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings.